Reporting patterns of adverse drug reactions over recent years in China: analysis from publications

Abstract

Purpose: The goal of this study was to clarify the reporting patterns of self-reported adverse drug reactions (ADRs) in China.

Methods: A variety of sources were searched, including the official website of China FDA, the national center for ADR monitoring center, publications from PubMed, and so on. We retrieved the relevant information and made descriptive and comparative analysis from the year 2009 to 2013.

Results: The ADR reporting numbers were 638,996, 692,904, 852,799, 1,200,000 and 1,317,000 from 2009 to 2013, respectively. Healthcare professionals contributed significantly, and their proportion always exceeded 80% before 2012. The average report per million inhabitants has increased from 479 to 983 from 2009 to 2013. However, the proportion of new or serious report was always below 25%. The reports mainly concern anti-infective agents and traditional Chinese medicine (TCM), especially TCM injection. The proportion of ADR reports in geriatric patients has increased for 4 consecutive years.

Conclusions: ADR report numbers and reporting rates in China are on the rise. However, the proportion of new or serious reports as well as the proportion of reports contributed by consumers and pharmaceutical companies are still quite low. More attention should be paid to the elderly, anti-infective agents and TCM, especially TCM injections.

Keywords:

• China
• pharmacovigilance
• reporting pattern
• self-reported adverse drug reaction

Acknowledgements

We are indebted to the primary sources of annual reports released by China Food and Drug Administration (CFDA), which used to be called State Food and Drug Administration (SFDA) before 2013. X -J Guo, X -F Ye and X -X Wang contributed equally to this work.

Declaration of interest

This study was conducted under three grants from the National Nature Science Foundation of China (81202285, 81373105, 31371344), a grant from Natural Science Foundation of Shanghai (12ZR1453700), the key discipline construction of evidence-based public health in Shanghai (12GWZX0602), and the Key Program of Shanghai Soft Science Research (14692101700). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

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